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The Association Between Herpes Simplex Viruses and Autism

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ClinicalTrials.gov Identifier: NCT03180112
Recruitment Status : Unknown
Verified June 2017 by Khalaf A Sayed, Assiut University.
Recruitment status was:  Not yet recruiting
First Posted : June 8, 2017
Last Update Posted : June 8, 2017
Sponsor:
Information provided by (Responsible Party):
Khalaf A Sayed, Assiut University

Brief Summary:
Autism spectrum disorders are pervasive developmental disorders that include autistic disorder, Asperger's disorder, and pervasive developmental disorder-not otherwise specified.They are characterized by stereotypic behaviors, variable deficits in language and social skills and a wide range of other behavioral problems. Autism spectrum disorders manifest during childhood and at least thirty percent present with sudden clinical regression of development around three years of age.

Condition or disease Intervention/treatment
Autism Spectrum Disorder Genetic: enzyme linked immunosorbent assay and polymerase chain reaction

Detailed Description:

Over the last twenty years, there has been an impressive rise in Autism spectrum disorders with current prevalence estimates being about one over one hundred children.

Herpes simplex virus encephalitis is the leading cause of sporadic, nonepidemic encephalitis in children and adults in the United States. It is an acute necrotizing infection generally involving the frontal and/or temporal cortex and the limbic system and, beyond the neonatal period, is almost always caused by Herpes simplex virus type on.

The etiology of autism is unknown; data suggest that autism results from multiple etiologies with both genetic and environmental contributions. One proposed etiology for autism is viral infection very early in development. The mechanism, by which viral infection may lead to autism, be it through direct infection of the central nervous system, through infection elsewhere in the body acting as a trigger for disease in the central nervous system, through alteration of the immune response of the mother or offspring, or through a combination of these, is not yet known.

Many encephalitic patients had temporal lobe involvement. Autism results from neuropathology relating to the temporal lobes. They speculate the differences in the extent and neuropathologies of the temporal lobes contribute to the heterogeneity of autism. Also, herpes viruses can induce a variety of proinflammatory cytokines during infections, along with elevated interferon in the brain during Herpes simplex virus encephalitis.

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Study Type : Observational
Estimated Enrollment : 80 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: The Association Between Herpes Simplex Viruses (Type One and Two) and Autism Spectrum Disorders
Estimated Study Start Date : August 1, 2017
Estimated Primary Completion Date : August 1, 2018
Estimated Study Completion Date : February 1, 2019

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
case group
Children suffering from Autism Spectrum disorders of variable grades attending to assiut University Children Hospital aged between six months and five years.
Genetic: enzyme linked immunosorbent assay and polymerase chain reaction
Blood samples will be collected and analyzed for herpes simplex viruses (type one and two) antibody by sensitive enzyme-linked immunosorbent assay and quantitative polymerase chain reaction.

control group
Healthy children of matching age and sex.
Genetic: enzyme linked immunosorbent assay and polymerase chain reaction
Blood samples will be collected and analyzed for herpes simplex viruses (type one and two) antibody by sensitive enzyme-linked immunosorbent assay and quantitative polymerase chain reaction.




Primary Outcome Measures :
  1. relationship between herpes simplex viruses infections and development of autism. [ Time Frame: 12 month ]
    Detection of herpes simplex viruses antibody titre by sensitive enzyme linked immunosorbent assay and detection of herpes simplex viruses titre by quantitative polymerase chain reaction


Biospecimen Retention:   Samples With DNA
quantitative polymerase chain reaction.


Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months to 5 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Children suffering from Autism Spectrum disorders of variable grades attending to Assuit University Children Hospital and the same number of healthy children of matching age and sex as a control.

Age between six months and five years

Criteria

Inclusion Criteria:

  1. Children suffering from Autism spectrum disorders.
  2. Age between six months and five years

Exclusion Criteria:

  1. Genetic disorders.
  2. History of metabolic or neurodegenerative disease.
  3. Gross motor delay.
  4. Audiologic problems.
  5. Mental retardation.
  6. Other psychiatric problems.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03180112


Contacts
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Contact: Gamal Ali Abdelal, MD +201111686162 Gamal.asker@med.au.edu.eg
Contact: Eman Ahmed Abdelraof, MD +201099696173 Emanaskar@hotmail.com

Sponsors and Collaborators
Assiut University
Publications:

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Responsible Party: Khalaf A Sayed, principle investigator, Assiut University
ClinicalTrials.gov Identifier: NCT03180112    
Other Study ID Numbers: HA
First Posted: June 8, 2017    Key Record Dates
Last Update Posted: June 8, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Herpes Simplex
Autistic Disorder
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Skin Diseases, Viral
Skin Diseases, Infectious
Skin Diseases